REvascularization RateS and Clinical OUtcomes With DABRA... | NCT04010045

Studies
REvascularization RateS and Clinical OUtcomes With DABRA Laser. A Long-Term 2-year Study

NCT04010045

Sponsor

Ra Medical Systems

Status

Terminated

Last Update Posted

Nov 3, 2021Actual

Enrollment

19Actual

Phase

Not provided

Conditions

Peripheral Artery Disease

Interventions

Endovascular Treatment of PAD

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Oct 2021

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Sponsor stopped the study for business reasons as site recruitment and subject enrollment have not met expectations.

Expanded Access Info

Start Date

May 2, 2019Actual

Primary Completion Date

Oct 15, 2020Actual

Completion Date

Oct 15, 2020Actual

First Submitted Date

Jun 4, 2019

First Submission Date that Met QC Criteria

Jul 3, 2019

First Posted Date

Jul 8, 2019Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Oct 27, 2021

Last Update Posted Date

Nov 3, 2021Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Yes

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

This is an observational study of the DABRA Laser System and other medical devices intended for endovascular treatment of peripheral artery disease.

Detailed Description

This is an observational, prospective, consecutively enrolled, single-arm, multi-site registry of the use of the DABRA Laser System and other medical devices intended for endovascular treatment of peripheral artery disease.

This study covers the use of endovascular devices including the DABRA Laser System and other devices commercially used in the United States for the treatment of lower extremity PAD.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

19Actual

Name	Type	Description	Arm Group Labels	Other Names
Endovascular Treatment of PAD	Device	PAD endovascular treatment using the DABRA Laser System + other FDA cleared/ approved devices for the treatment of PAD.		PAD endovascular treatment using the DABRA Laser System

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Vessel Patency	Patency of the target lesion at 24 months, as determined by duplex ultrasound.	24 months

Secondary Outcomes

Measure	Description	Time Frame
Serious Adverse Events	Tabulation of serious adverse events at 1 day, 6 months, 12 months, 18 months, and 24 months	1 day, 6 months, 12 months, 18 months, and 24 months
Vessel Patency	Patency of the target lesion at 6 months, 12 months, and 18 months, as determined by duplex ultrasound.

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Participant's age ≥ 22 years.
Participant presents with a Rutherford category of 2 to 6.
Participant has at least one peripheral lesion, ≤ 140mm, in a native vessel that is treated successfully with DABRA Laser System.
Participant is able and willing to be anti-coagulated.
Ability and willingness of participant to give written informed consent and comply with follow-up.

Exclusion Criteria:

Pregnant, breastfeeding, planning to become pregnant - If women of reproductive capability will be enrolled, status will be assessed via pregnancy testing. Subject must agree to use effective birth control measures for duration of study. Pregnancy during study must be reported immediately.
Endovascular interventions within 90 days prior to study enrollment (on leg to be treated).
Participation in another cardiovascular or peripheral vascular study that might, in the judgement of the Investigator, affect the results of the study.
Disorders or allergies precluding use of radiographic contrast including renal insufficiency severe enough to contraindicate use of radiographic contrast.
Inability or unwillingness of the patient to comply with study examinations.
Necrosis necessitating major amputation.
Subject has an anticipated life span of less than one (1) year.
Medically non-compliant subjects, based on Investigator judgment (e.g., subject is non-compliant in following medical advice regarding blood pressure medication, cholesterol medication, and/or maintenance of healthy blood sugar levels).
No run-off vessel is present when treating above the knee. A run-off vessel is required when treating above the knee, however, it is not required when treating below the knee.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

22 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

The target population for this study is patients presenting with symptoms of peripheral artery disease.

Sampling Method

Non-Probability Sample

ID	Term
D050197	Atherosclerosis
D001161	Arteriosclerosis
D001157	Arterial Occlusive Diseases
D014652	Vascular Diseases